The purpose of this study is to investigate the relationship between your cardiovascular fitness and your body’s immune response, as both may be related to fatigue (tiredness), mood, pain sensitivity, memory, and concentration—known side effects of cancer and its treatments. By learning if people with better cardiovascular fitness have lower inflammation, researchers will be able to discover whether and how regular exercise benefits breast cancer survivors.
If you agree to participate in the Inflammatory Responses, Mood, and Physical Fitness after Cancer Treatment (IMPACT) Study, you will be asked to participate in two screening appointments (2 hours each) and two non-consecutive 9.5-hour study days. The first screening visit and both full day visits will take place at the Clinical Research Center at the Ohio State University Wexner Medical Center. The second screening appointment will take place at the Davis Heart and Lung Research Institute, also in the Ohio State medical complex.
The two screening appointments are often scheduled in a single screening visit for convenience. At the first appointment, you will have your blood drawn (less than a tablespoon) to test for diabetes and anemia, then answer questions about your mood, health, and attitudes. At the second appointment, with physician consent you will be asked to complete a brief exercise test on a stationary bike for 6-12 minutes to measure your level of fitness.
If you are able to participate in the full study, you will then be scheduled for two 9.5-hour visits at the Clinical Research Center. These two visits will be scheduled on a weekday and must take place at least one month apart. These visits will include blood draws, saliva samples, body measurements, questionnaires, and interviews.
• On the full-day study, a catheter (a small, hollow plastic tube) will be inserted into a vein in your arm so that small amounts of blood can be drawn at different times across the visit. The catheter will be removed at the end of each visit.
• The nurse will administer an injection into your upper arm that contains either saline (salt water) or a typhoid vaccine. This is the same vaccine given to people who are traveling to southeast Asia. It has minimal side effects, comparable to those of a flu vaccine, and is used in the study to stimulate the immune system. During both visits, your metabolic response to the vaccine and the placebo will be measured 6-8 times. In order for the researchers to obtain this information, you will need to lie on a hospital bed with a facemask that covers your nose and mouth for 10-25 minutes.
At each of the two 9.5-hour visits you will be given free parking, breakfast, and lunch. You will also receive a detailed report about your eating patterns, your average daily intake of different nutrients and recommendations for improving your diet, your body composition, bone mineral density, and resting metabolic rate, and your current fitness level. For the duration of the study (both screening and study visits) you will also be compensated for your time.